FDA Adverse Event
Injury
Summary report: N
BODYSCULP
MDR report key: 21396365
·
Received February 18, 2025
Report
- Report Number
- 3031944951-2025-00001
- Event Type
- Injury
- Date Received
- February 18, 2025
- Date of Event
- December 20, 2024
- Report Date
- February 16, 2025
- Manufacturer
- ROHRER AESTHETICS, INC.
- Product Code
- PKT
- PMA / PMN Number
- K212331
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
BECAUSE ORIGINAL REPORTER DID NOT GIVE ADDRESS, CLINIC OR USER FACILITY INFORMATION, WE WERE UNABLE TO INVESTIGATE HER SPECIFIC CONCERN. WE INVESTIGATED OUR CURRENT COMPLAINT FILES TO SEE IF WE COULD MATCH THIS CASE UP TO ONE ON FILE AND HAD NO FINDINGS.
Description of Event or Problem · 0
ROHRER AESTHETICS WAS INFORMED OF THE ADVERSE EVENT THROUGH THE FDA MEDWATCH VOLUNTARY SYSTEM REPORT NUMBER MW51641178. PATIENT CLAIMS THAT THE BODYSCULP CAUSED "SERIOUS BURNS FROM THE INSIDE OUT".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1178755 | BODYSCULP | LOW LEVEL LASER FOR AESTHETIC USE | PKT | ROHRER AESTHETICS, INC. | BODYSCULP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Female | Other |